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Infect Immun, July 1998, p. 3095-3099, Vol. 66, No. 7
0019-9567/98/$04.00+0
Copyright © 1998, American Society for Microbiology. All rights reserved.

Phase 1 Evaluation of Vibrio cholerae O1, Serotype Inaba, Polysaccharide-Cholera Toxin Conjugates in Adult Volunteers

Rajesh K. Gupta,1,dagger David N. Taylor,2 Dolores A. Bryla,1 John B. Robbins,1 and Shousun C. Szu1,*

Laboratory of Developmental and Molecular Immunity, National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland 20892-2720,1 and Walter Reed Army Institute for Research, Washington, D.C. 20307-51002

Received 22 December 1997/Accepted 13 April 1998

Conjugate vaccines were prepared by binding hydrazine-treated lipopolysaccharide (DeALPS) from Vibrio cholerae O1, serotype Inaba, to cholera toxin (CT) variants CT-1 and CT-2. Volunteers (n = 75) were injected with either 25 µg of DeALPS, alone or as a conjugate, or the licensed cellular vaccine containing 4 × 109 organisms each of serotypes Inaba and Ogawa per ml. No serious adverse reactions were observed. DeALPS alone did not elicit serum LPS or vibriocidal antibodies in mice and only low levels of immunoglobulin M (IgM) anti-LPS in the volunteers. Recipients of the cellular vaccine had the highest IgM anti-LPS levels, but the difference was not statistically significant from that elicited by the conjugates. The conjugates elicited the highest levels of IgG anti-LPS (DeALPS-CT-2 > DeALPS-CT-1 > cellular vaccine). Both conjugates and the cellular vaccine elicited vibriocidal antibodies: after 8 months, recipients of cellular vaccine had the highest geometric mean titer (1,249), followed by DeALPS-CT-2 (588) and DeALPS-CT-1 (330). The correlation coefficient between IgG anti-LPS and 2-mercaptoethanol (2-ME)-resistant vibriocidal antibodies was 0.81 (P = 0.0004). Convalescent sera from cholera patients had a mean vibriocidal titer of 2,525 that was removed by treatment with 2-ME. The vibriocidal activities of sera from all vaccine groups and from the patients were absorbed (>75%) by LPS but not by either CT-1 or CT-2. Conjugate-induced IgG vibriocidal antibodies persisted longer than those elicited by the whole-cell vaccine. Both conjugates, but not the cellular vaccine, elicited IgG anti-CT.

* Corresponding author. Mailing address: Building 6, Room 424, NIH, 8800 Rockville Pike, Bethesda, MD 20892. Phone: (301) 496-1185. Fax: (301) 402-9108. E-mail: scszu{at}Helix.nih.gov.

dagger Present address: Wyeth-Lederle Vaccines and Pediatrics, Pearl River, NY 10965.

Infect Immun, July 1998, p. 3095-3099, Vol. 66, No. 7
0019-9567/98/$04.00+0
Copyright © 1998, American Society for Microbiology. All rights reserved.


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